Phase I Plan definition

Phase I Plan means, for each Collaboration Target, a plan and budget describing the one or more Phase I Studies to be conducted with respect to such Collaboration Target in the Field that will be established and approved by the JDC, with the goal to provide the Option Data Package for such Collaboration Target.
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Phase I Plan means, for a Phase I Completed Original Product, a plan describing the performance of the Phase I Study for such Phase I Completed Original Product, which is prepared jointly by C4T and Roche and approved by the JDC.
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Phase I Plan means the Company's installation of voice and data switches in Seattle, Washington; Portland, Oregon; Denver, Colorado; and Minneapolis, Minnesota, along with related workforce build-out in such cities and in Reno, Nevada.
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Examples of Phase I Plan in a sentence

  • The ESC Phase I Plan Sheet shall, at a minimum, depict the following: - Existing contours and appropriate existing hydraulic and topographic features as referenced in the Survey File.

  • Men detta leder också ibland till att min mejlkorg hamnar sekundärt till att närvaro på möten vilket är varför jag anser att min arbetsbelastning kanske är aningen högre än senast.Samtidigt fylls jag med motivation varje dag jag går till jobbet.

  • In general, when utilizing a separate plan sheet for the Phase I and the Phase II plan details, erosion and sediment control items (including protective linings in permanent ditches and channel relocations) depicted on the Phase I Plan Sheet should not be duplicated on the Phase II Plan Sheet.

  • Generally, the Phase I and the Phase II plan details (including associated narratives or notes) should each be depicted on a separate plan sheet following the applicable construction plan sheet (e.g., Construction Plan Sheet 5, Profile Sheet 5A, ESC Phase I Plan Sheet 5B, ESC Phase II Plan Sheet 5C).

  • Rather the Vermont Lake Champlain Phosphorus TMDL Phase I Implementation Plan (Phase I Plan) and the accountability framework lay out the necessary activities that must be completed as well as a schedule for completing them to achieve the overall reductions required by the LCTMDL.

  • The schedule calls for completing the Phase I Plan within 12 months.

  • Appendix B.2. details the Phase I Plan projects involving heavy cleaning, structural improvement and structural and priority meter basin rehabilitation as described in the approved sewershed evaluation plans for the respective sewersheds.

  • AppendixB.1 details the Phase I Plan projects for the Back River Wastewater Treatment Plant headworks modifications.

  • These impacts represent the economic costs in terms of jobs, income, and business sales to other Maryland businesses of the Phase I Plan.

  • EPA and MDE approved the Phase I Plan list of projects on November 2, 2013.


More Definitions of Phase I Plan

Phase I Plan. The plan will establish restoration priorities and criteria for selecting restoration projects over the next ten years. Specific elements will include, but may not be limited to, restoration and permanent protection of riparian vegetation, restoration of stream channel functions, remediation of fish passage problems, and prevention of entrainment of fish into diversions.
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Phase I Plan. Phase I Plan means the plan for the Phase I Research Trial set forth on EXHIBIT C to this Agreement, as such plan may be modified from time to time pursuant to Section 2.1.2, which sets forth the genetic, clinical and statistical parameters for the Phase I Research Trial.
Sample 1

Related to Phase I Plan

  • Phase 1 means the first implementation phase of this section, beginning June 1, 2018 and ending May 31, 2022.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Redevelopment Plan means the “Lincoln Center Redevelopment Plan” passed, adopted and approved by the City pursuant to the Resolution, and shall include any amendment of said Redevelopment Plan heretofore or hereafter made by the City pursuant to law.

  • Phase I Trial means a clinical trial of a Licensed Product in human patients conducted primarily for the purpose of determining the safety, tolerability and preliminary activity of the Licensed Product, including, without limitation, for determining the maximum tolerated dose, or optimal dose. For purposes of this Agreement, a Phase I trial shall specifically exclude a study in healthy volunteers.

  • Phase II Study means a study in humans of the safety, dose ranging or efficacy of a product, as further defined in 21 C.F.R. § 312.21(b) (or the equivalent thereof outside the United States).

  • Phase III means human clinical trials, the principal purpose of which is to establish substantial evidence of both safety and efficacy in patients with the disease or condition being studied, as more fully defined in 21 C.F.R. §312.21(c) or similar clinical study in a country other than the United States. Phase III shall also include any other human clinical trial intended to serve as a pivotal trial to support the submission of an application for regulatory approval.

  • Program Plan means the tobacco settlement program plan dated February 14, 2001, including exhibits to the program plan, submitted by the authority to the legislative council and the executive council, to provide the state with a secure and stable source of funding for the purposes designated by section 12E.3A and other provisions of this chapter.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • Phase 2 means the second implementation phase of this section, beginning June 1, 2022 and continuing thereafter.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Phase II Trial means a clinical trial of a Licensed Product on patients, including possibly pharmacokinetic and dose ranging studies, the principal purposes of which are to make a preliminary determination that such Licensed Product is safe for its intended use and to obtain sufficient information about such Licensed Product’s efficacy to permit the design of further clinical trials, and generally consistent with 21 CFR §312.21(b), or its successor regulation, or the equivalent in any foreign country.

  • Project area plan means a written plan that, after the plan's effective date, guides and controls the development within a project area.

  • Development Plan has the meaning set forth in Section 3.2.

  • Phase I assessment as described in, and meeting the criteria of, (i) Chapter 5 of the FNMA Multifamily Guide or any successor provisions covering the same subject matter in the case of a Specially Serviced Mortgage Loan as to which the related Mortgaged Property is multifamily property or (ii) the American Society for Testing and Materials in the case of Specially Serviced Mortgage Loan as to which the related Mortgaged Property is not multifamily property.

  • Improvement Plan means the plan required by the Authority from the Supplier which shall detail how the Supplier will improve the provision of the Goods and/or Services pursuant to Clause 29.1.1 (Authority Remedies);

  • Phase II means the second part of the tuition incentive assistance program which provides assistance in the third and fourth year of 4-year degree programs.

  • The Project Plan means the document to be developed by the Supplier and approved by the Purchaser, pursuant to GCC Clause 19, based on the requirements of the Contract and the Preliminary Project Plan included in the Supplier’s bid. The “Agreed and Finalized Project Plan” is the version of the Project Plan approved by the Purchaser, in accordance with GCC Clause 19.2. Should the Project Plan conflict with the Contract in any way, the relevant provisions of the Contract, including any amendments, shall prevail.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Development Site means any parcel or lot on which exists or which is intended for building development other than the following:

  • Phase 2 Trial means a human clinical trial conducted on study subjects with the disease or condition being studied for the principal purpose of achieving a preliminary determination of efficacy or appropriate dosage ranges, as further described in 21 C.F.R. §312.21(b) (including any such clinical study in any country other than the United States).

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase 3 means the period commencing on the day after the Phase 2 implementation date and ending on the Phase 3 implementation date (as defined below).

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.